DIALOG+®
Report
- Report Number
- 3002879653-2018-00003
- Event Type
- Death
- Date Received
- March 8, 2018
- Date of Event
- February 24, 2018
- Report Date
- May 16, 2018
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- KDI
- UDI-DI
- 04046963686345
- PMA / PMN Number
- K963440
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). THE DEVICE INVOLVED WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE TREND DATA WAS PROVIDED AND REVIEWED. A PRELIMINARY REVIEW OF THE TREND DATA SHOWS THE MACHINE WORKED AND REACTED IN EACH CASE AS INTENDED. ALSO, THERE IS NO EVIDENCE OF A MALFUNCTION OF THE DEVICE. AT THE ESTIMATED TIME OF THE PATIENT'S MEDICAL STATUS CHANGE, THE MACHINE TRIGGERED SEVERAL ALARMS RECOGNIZING THIS CHANGE. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). THE DEVICE INVOLVED WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE TREND DATA WAS PROVIDED. THE ANALYSIS OF THE TREND DATA RECORD OF THE DIALOG+ DIALYSIS MACHINE SHOWED AN INCONSPICUOUS PREPARATION PHASE. DURING THERAPY THE ALARM "TMP OUT OF ALARM LIMITS" (ALARM CODE 1015) WAS TRIGGERED VERY OFTEN BECAUSE THE TRANSMEMBRANE PRESSURE WAS LOW DURING THE WHOLE THERAPY. STARTING ABOUT 2 HOURS INTO THERAPY THE ARTERIAL PRESSURE DECREASED SLOWLY FROM APPROXIMATELY -200 MMHG TO -309 MMHG UNTIL 20 MINUTES LATER AT 12:44 [HH:MM]. THE DIALOG+ MACHINE TRIGGERED NO ALARM BECAUSE THE ARTERIAL PRESSURE WAS STILL ABOVE THE LOWER LIMIT. THE DECREASE OF THE ARTERIAL PRESSURE MEASURED BY THE DIALYSIS MACHINE MIGHT INDICATE THE PATIENT'S BLOOD PRESSURE DROP AS DESCRIBED. IN ADDITION, THE VENOUS PRESSURE SLOWLY INCREASED UNTIL THE UPPER LIMIT WAS EXCEEDED AND THE ALARM "VENOUS PRESSURE - UPPER LIMIT" (ALARM CODE 1052) WAS TRIGGERED. FURTHER VENOUS AND ARTERIAL PRESSURE ALARMS FOLLOWED BECAUSE THE RESPECTIVE RANGE WAS EXCEEDED. AT 12:45 [HH:MM] ACCORDING TO THE DATA RECORDED IN THE TREND FILE, THE RED DETECTOR (RDV) SENSOR CHANGED THE VALUE FROM 1 TO 0, MEANING THAT NO "RED" WAS DETECTED, AN INDICATION THAT THE PATIENT WAS TAKEN OFF THE MACHINE. THIS MATCHES THE REPORTED TIME OF THE DISCONNECTION OF THE PATIENT. ALL ALARMS WERE TRIGGERED BECAUSE THE ALARM CONDITIONS WERE MET AND THE MACHINE REACTED AS SPECIFIED. THE TREND DATA DOES NOT GIVE ANY EVIDENCE OF A MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE. THIS WAS CONFIRMED BY THE ON-SITE INSPECTION OF THE DIALOG+ MACHINE BY THE CUSTOMER'S TECHNICIAN. SINCE THERE WAS NO MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE, NO FURTHER ACTIONS WILL BE TAKEN. B. BRAUN WILL CONTINUE TO INVESTIGATE, TREND, AND MONITOR ALL COMPLAINTS OF THIS NATURE.
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). THE DEVICE INVOLVED WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE TREND DATA WAS PROVIDED. THE ANALYSIS OF THE TREND DATA RECORD OF THE DIALOG+ DIALYSIS MACHINE SHOWED AN INCONSPICUOUS PREPARATION PHASE. DURING THERAPY THE ALARM "TMP OUT OF ALARM LIMITS" (ALARM CODE 1015) WAS TRIGGERED VERY OFTEN BECAUSE THE TRANSMEMBRANE PRESSURE WAS LOW DURING THE WHOLE THERAPY. STARTING ABOUT 2 HOURS INTO THERAPY THE ARTERIAL PRESSURE DECREASED SLOWLY FROM APPROXIMATELY -200 MMHG TO -309 MMHG UNTIL 20 MINUTES LATER AT 12:44 [HH:MM]. THE DIALOG+ MACHINE TRIGGERED NO ALARM BECAUSE THE ARTERIAL PRESSURE WAS STILL ABOVE THE LOWER LIMIT. THE DECREASE OF THE ARTERIAL PRESSURE MEASURED BY THE DIALYSIS MACHINE MIGHT INDICATE THE PATIENT'S BLOOD PRESSURE DROP AS DESCRIBED. IN ADDITION, THE VENOUS PRESSURE SLOWLY INCREASED UNTIL THE UPPER LIMIT WAS EXCEEDED AND THE ALARM "VENOUS PRESSURE - UPPER LIMIT" (ALARM CODE 1052) WAS TRIGGERED. FURTHER VENOUS AND ARTERIAL PRESSURE ALARMS FOLLOWED BECAUSE THE RESPECTIVE RANGE WAS EXCEEDED. AT 12:45 [HH:MM] ACCORDING TO THE DATA RECORDED IN THE TREND FILE, THE RED DETECTOR (RDV) SENSOR CHANGED THE VALUE FROM 1 TO 0, MEANING THAT NO "RED" WAS DETECTED, AN INDICATION THAT THE PATIENT WAS TAKEN OFF THE MACHINE. THIS MATCHES THE REPORTED TIME OF THE DISCONNECTION OF THE PATIENT. ALL ALARMS WERE TRIGGERED BECAUSE THE ALARM CONDITIONS WERE MET AND THE MACHINE REACTED AS SPECIFIED. THE TREND DATA DOES NOT GIVE ANY EVIDENCE OF A MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE. SINCE THERE WAS NO MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE, NO FURTHER ACTIONS WILL BE TAKEN. B. BRAUN WILL CONTINUE TO INVESTIGATE, TREND, AND MONITOR ALL COMPLAINTS OF THIS NATURE. CORRECTED DATA: BASED ON COMMUNICATION FROM THE END CUSTOMER, THEIR BIOMED DEPARTMENT DID NOT INSPECT THE MACHINE AS NO ONE IN THEIR DEPARTMENT WAS TRAINED TO WORK ON THE DEVICE. THE B. BRAUN SERVICE TECHNICIAN INSPECTED THE MACHINE FOR ANY ABNORMALITIES IN OPERATION.
AS REPORTED BY THE USER FACILITY: A NURSE REPORTED TO A B. BRAUN AVITUM TECHNICIAN THAT A PATIENT EXPIRED WHILE CONNECTED TO A MACHINE. MEDICAL INTERVENTION WAS NECESARY AND CONSISTED OF CHEST COMPRESSIONS. PATIENT WITH A DIAGNOSIS OF KIDNEY FAILURE, 76 Y.O. MALE, CONNECTED TO DIALYSIS MACHINE AT 10:50AM. VS WNL, PATIENT WITHOUT ANY VISIBLE SIGNS OF PAIN OR DISTRESS. MACHINE FUNCTIONING WELL, NO MALFUNCTIONING MESSAGES OR ALARMS. AT 11:20AM - VITAL SIGNS REMAIN NORMAL, PATIENT WITHOUT ANY COMPLAINTS OR VISIBLE SIGNS OF PAIN/DISTRESS. AT 12:20AM - BLOOD PRESSURE 170/103, HEART RATE NORMAL, RESPIRATIONS NORMAL. PATIENT WITHOUT ANY COMPLAINTS. AT 12:48 - BLOOD PRESSURE P 85/50, RESPIRATORY DISTRESS NOTED, INCREASED HEART RATE. AT 12:50 - CPR INITIATED, 911-EMS CALLED. AT 1:00 - EMS ARRIVED - PATIENT TRANSFERRED TO EMERGENCY ROOM - EXPIRED IN EMERGENCY ROOM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER'S BIOMED DEPARTMENT. THE MACHINE WAS EVALUATED AND IT WAS FOUND THAT THE MACHINE WAS FUNCTIONING WITHOUT ANY DIFFICULTY. NO WORK/REPAIR REQUIRED, MACHINE WAS RETURNED TO DIALYSIS UNIT FOR USE.
AS REPORTED BY THE USER FACILITY: A NURSE REPORTED TO A B. BRAUN AVITUM TECHNICIAN THAT A PATIENT EXPIRED WHILE CONNECTED TO A MACHINE. MEDICAL INTERVENTION WAS NECESARY AND CONSISTED OF CHEST COMPRESSIONS. PATIENT WITH A DIAGNOSIS OF KIDNEY FAILURE, 76 Y.O. MALE, CONNECTED TO DIALYSIS MACHINE AT 10:50AM. VS WNL, PATIENT WITHOUT ANY VISIBLE SIGNS OF PAIN OR DISTRESS. MACHINE FUNCTIONING WELL, NO MALFUNCTIONING MESSAGES OR ALARMS. AT 11:20AM - VITAL SIGNS REMAIN NORMAL, PATIENT WITHOUT ANY COMPLAINTS OR VISIBLE SIGNS OF PAIN/DISTRESS. AT 12:20AM - BLOOD PRESSURE 170/103, HEART RATE NORMAL, RESPIRATIONS NORMAL. PATIENT WITHOUT ANY COMPLAINTS. AT 12:48 - BLOOD PRESSURE P 85/50, RESPIRATORY DISTRESS NOTED, INCREASED HEART RATE. AT 12:50 - CPR INITIATED, 911-EMS CALLED. AT 1:00 - EMS ARRIVED - PATIENT TRANSFERRED TO EMERGENCY ROOM - EXPIRED IN EMERGENCY ROOM. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER'S BIOMED DEPARTMENT. THE MACHINE WAS EVALUATED AND IT WAS FOUND THAT THE MACHINE WAS FUNCTIONING WITHOUT ANY DIFFICULTY. NO WORK/REPAIR REQUIRED, MACHINE WAS RETURNED TO DIALYSIS UNIT FOR USE.
AS REPORTED BY THE USER FACILITY: A NURSE REPORTED TO A B. BRAUN AVITUM TECHNICIAN THAT A PATIENT EXPIRED WHILE CONNECTED TO A MACHINE. MEDICAL INTERVENTION WAS NECESARY AND CONSISTED OF CHEST COMPRESSIONS. PATIENT WITH A DIAGNOSIS OF KIDNEY FAILURE, 76 Y.O. MALE, CONNECTED TO DIALYSIS MACHINE AT 10:50AM. VS WNL, PATIENT WITHOUT ANY VISIBLE SIGNS OF PAIN OR DISTRESS. MACHINE FUNCTIONING WELL, NO MALFUNCTIONING MESSAGES OR ALARMS. AT 11:20AM - VITAL SIGNS REMAIN NORMAL, PATIENT WITHOUT ANY COMPLAINTS OR VISIBLE SIGNS OF PAIN/DISTRESS. AT 12:20AM - BLOOD PRESSURE 170/103, HEART RATE NORMAL, RESPIRATIONS NORMAL. PATIENT WITHOUT ANY COMPLAINTS. AT 12:48 - BLOOD PRESSURE P 85/50, RESPIRATORY DISTRESS NOTED, INCREASED HEART RATE. AT 12:50 - CPR INITIATED, 911-EMS CALLED. AT 1:00 - EMS ARRIVED - PATIENT TRANSFERRED TO EMERGENCY ROOM - EXPIRED IN EMERGENCY ROOM. THE MACHINE WAS EVALUATED AND IT WAS FOUND THAT THE MACHINE WAS FUNCTIONING WITHOUT ANY DIFFICULTY. NO WORK/REPAIR REQUIRED, MACHINE WAS RETURNED TO DIALYSIS UNIT FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167087 | DIALOG+® | HIGH PERMEABILIT | KDI | B. BRAUN AVITUM AG - MELSUNGEN | 710200L | 04046963686345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |